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The National Institute of Neurological Disorders and Stroke, part of the National Institutes of Health, is looking for individuals to participate in clinical studies. Participating in clinical trials allows you to play an active role in research on the nature and causes of many disorders of the brain and nervous system, and to possibly help physician-scientists develop future treatments. The information below is designed to help you quickly learn about actively recruiting research studies for which you or someone you know may be eligible.

Description:

Some people who have brain tumors have seizures related to the tumor, which is a condition called tumor-related epilepsy. The standard treatment for people with brain tumors is surgery to remove as much of the tumor as possible without causing additional neurological problems. Researchers think this method of treatment may improve the outcome for people with brain tumors because it may completely relieve or greatly reduce the number of seizures they experience.

This research study (16-N-0041) will evaluate and offer surgery to people with tumor-related epilepsy, and explore how surgery affects seizures. One hundred participants will be enrolled in this study. Eligible participants will be screened with a physical examination; a review of their medical history; a neurological exam; tests of memory, attention and thinking; questions about their symptoms and quality of life; and a blood draw. Participants also may have magnetic resonance imaging (MRI) or computed tomography (CT) scans and/or video electroencephalography.

In the study, participants will undergo surgery to remove their brain tumor and will keep a seizure diary before and after surgery. They will stay in the hospital up to a week after surgery and will have follow-up visits at NIH. Researchers will examine changes in the seizures, MRI scans, cognitive function, and general quality of life before and after surgery. Some brain tissue removed during surgery will be used for diagnostic purposes. The remainder may be used for research studies. There is no cost for participation in this study.

Knowledge gained from this research may lead to future advances in the treatment of people with tumor-related epilepsy.

Eligibility Criteria:

INCLUSION CRITERIA: To be eligible for entry into the study, a candidate must meet all the following criteria:

Be 8 years of age or older.

Have solitary primary or recurrent brain tumor with associated seizures. Brain tumor may be diagnosed radiologically. Associated seizures are defined as those with activity starting within three months of radiologic diagnosis of the primary or recurrent tumor. In cases when the timing of seizure activity is unclear with respect to the timing of diagnosis, seizures will be considered associated with the tumor if seizure semiology is consistent with that location. Ongoing seizures are not required. Patients can be included if they have had a single previous seizure. Patients who have not experienced seizures after institution of anti-convulsant therapy are not excluded.

Agree to undergo brain surgery.

Willing and able to appoint a durable power of attorney.

EXCLUSION CRITERIA: Candidates will be excluded if they:

Have a bleeding disorder that cannot be corrected before invasive testing or surgery, or other medical conditions that would make surgery unsafe, such as lung or cardiac disease that would render them unable to tolerate the risk of general anesthesia, or severe immunodeficiency or systemic cancer not related to a brain lesion.

Cannot have an MRI scan.

Have multiple brain tumors, evidence of carcinomatous meningitis, gliomatosis cerebri, or primary CNS lymphoma. Patients with multiple metastatic lesions that for which surgery is not indicated will be exluded. Patients with peripheral neurological or systemic metabolic disorders that cause seizures will be excluded.

Have an underlying seizure disorder that is unrelated to the brain tumor, or underlying neurological disorder that is unrelated to the brain tumor and that may contribute to seizure activity.

At the time of enrollment, lack consent capacity due to cognitive impairment that would make them incapable of understanding the explanation of the procedures in this study. Cognitive capacity to consent will be determined at the time of enrollment. Patients with mental disorders or those patients who are cognitively impaired yet still retain consent capacity will not be excluded. Children may be enrolled if there is a parent or guardian able to consent on their behalf.